From
MarketWatch:
Final results from a 24-week study presented today at a major medical meeting in Barcelona suggest that investigational olanzapine long-acting injection (LAI) therapeutic doses showed a maintenance of treatment benefit for up to six months. A review of pooled safety data from all olanzapine LAI clinical trials was also presented at the meeting.
Olanzapine LAI is an investigational formulation that combines
Zyprexa(R) (olanzapine), an atypical antipsychotic, with pamoic acid resulting in a salt that sustains the delivery of olanzapine for a period of up to four weeks. Long-acting injectable antipsychotics have been associated with improved treatment of schizophrenia in patients who have difficulty adhering to daily treatment regimens.
"These studies offer insight into the role olanzapine LAI may play in the treatment of patients with schizophrenia who have benefited from olanzapine but continue to struggle with adherence," said David McDonnell, M.D., clinical research physician at Lilly. "If approved, olanzapine LAI could be a valuable treatment option due to the chronic and severe nature of schizophrenia, persistent challenges with adherence and the limited number of available depot formulations."
Independent regulatory reviews of olanzapine LAI applications are ongoing in the European Union, Canada, Australia and United States. Olanzapine LAI is currently being reviewed by CHMP and submission to regulators to obtain country-specific marketing approval is dependent upon a CHMP opinion.